FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COMPUDENT STA
K Number: K061904
·
Decision Aug 8, 2006
Classifications
1
FEI Numbers
74
Registration Numbers
74
Same Product Code
44
Applicant Total
4
Review Days
34
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- COMPUDENT STA
- K Number
- K061904
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.6770
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Milestone Scientific, Inc.
- Date Received
- July 5, 2006
- Decision Date
- August 8, 2006
- Product Code
- EJI
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| EJI | Syringe, Cartridge | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EJI), ordered by most recent decision date.
LeEject 2 Dental Syringe and Needle System
FDA 510(k)
FDA Class 2
·Dental
Miltex N-Tralig Intraligamentary Syringe
FDA 510(k)
FDA Class 2
·Dental
HU-FRIEDY DENTAL CARTRIDGE SYRINGE
FDA 510(k)
FDA Class 2
·Dental
ANESTHESIA INJECTION TOOL SET
FDA 510(k)
FDA Class 2
·Dental
MORPHEUS
FDA 510(k)
FDA Class 2
·Dental
ASPIRATING SYRINGE, NON-ASPIRATING SYRINGE
FDA 510(k)
FDA Class 2
·Dental